Sleep Apnea Screening

Arrhythmia Network Technology S.L.15 enrolled

Overview

To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sleep Apnea/Hypopnea Syndrome

Interventions

Berlin and Epworth questionariesOTHER

Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.OTHER

Night polygraph / PolysomnographyOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older * No previous diagnosis of sleep apnea * Fulfilling at least one of the following: 1. Pacemaker indication 2. ICD or CRTD therapy indication 3. Heart failure and preserved LVEF (40-50%) 4. Heart failure and reduced LVEF (\<40%) * Signed informed consent Exclusion Criteria: * Age younger than 18 years * Renal hemodialysis * Cardiac transplant indication * Women who are pregnant * Advanced cancer * Enrollment in another investigational study * Able and willing to comply with all testing and requirements * Patient not suitable for inclusion due to psychiatric conditions or short life expectancy

Locations (9)

Hospital Nuestra Señora de Sonsoles

Ávila, Spain

Hospital Infanta Cristina

Badajoz, Spain

Hospital Universitario de Burgos

Burgos, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

Outcomes

Primary Outcomes

Percentage of patients with SAHS in patients with pacemaker indication

Time frame: 1 month

Percentage of patients with SAHS in patients with ICD or CRTD therapy

Time frame: 1 month

Percentage of patients with SAHS in patients with heart failure and preserved LVEF

Time frame: 1 month

Percentage of patients with SAHS in patients with reduced LVEF

Time frame: 1 month

Secondary Outcomes

Percentage of patients with obstructive sleep apnea in all groups

Time frame: 1 month

Percentage of patients with central sleep apnea in all groups

Time frame: 1 month

Data from ClinicalTrials.gov

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